This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination.

The immunogenicity and reactogenicity of PCV13 in the "standard schedule" groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).

Adverse events following immunization [ Time Frame: 1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance) ] [ Designated as safety issue: Yes ]

Serotype-specific serum IgG [ Time Frame: in infants, at 9 months and 10 months of age ] [ Designated as safety issue: No ]

Infants receiving PCV13 at 6 weeks, 14 weeks and 9 months. Note: This infant immunization schedule is used in many European countries and in South Africa and has been shown to be immunogenic and effective. However, few head-to-head comparisons of the 2+1 and 3+0 schedules have been conducted.

Biological: Prevnar13 (manufactured by Pfizer)

PCV13 administered IM in the antero-lateral thigh

Active Comparator: Infants 3+0

Infants receiving PCV13 at 6, 10 and 14 weeks

Biological: Prevnar13 (manufactured by Pfizer)

PCV13 administered IM in the antero-lateral thigh

Eligibility

Ages Eligible for Study:

up to 4 Years (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Infants inclusion criteria

Child has birth weight ≥ 2500g

Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant

Mother has resided in Burkina Faso for at least 2 years

Mother has African nationality

Child will reside in Bobo-Dioulasso urban area for the duration of the study

Parent or guardian has given informed consent for child's participation

Child received a pneumococcal vaccine outside the context of the trial

Child's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children

Blood draw at first vaccination visit was unsuccessful after 3 attempts

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577771